|By Marketwired .||
|July 7, 2014 07:00 AM EDT||
BEVERLY, MA -- (Marketwired) -- 07/07/14 -- Cellceutix (OTCQB: CTIX) announced another important milestone in the development of Brilacidin, the lead compound in a novel class of antibiotics known as defensin-mimetics. In the Company's phase 2b study on patients with acute bacterial skin and skin structure infections (ABSSSI), an independent Data Safety Monitoring Board (DSMB) gave a positive review of interim safety data, collected after approximately 50% of the subjects were enrolled. The DSMB is composed of two cardiologists, one neurologist, and one statistician, and its mandate is to monitor and promote the safety of study participants.
The DSMB recommended that Cellceutix continue the trial as planned. That is the best possible outcome. Independent experts did not observe any concerning safety signals in the study. In addition, the Company reports there are no treatment-related Serious Adverse Events (SAEs), and none classified as cardiovascular or neurological, thus far in the study.
Previous brilacidin phase 1 and 2 studies have indicated the drug is safe and effective in the treatment of ABSSSI caused by Staph aureus, including methicillin-resistant Staph aureus (MRSA). Any treatment-related adverse events in past trials were more likely due to a higher total dose of study drug. However, in the current study, brilacidin is given as a single-dose regimen in two treatment arms (0.6 or 0.8 mg/kg), and in the third arm, it is given as a 3-day regimen, which represents the highest amount a subject could receive (total 1.2 mg/kg). Of note, the highest amount is still lower than the lowest amount of brilacidin given in the previous phase 2 ABSSSI study, which concluded in 2012.
Mr. Ehrlich commented, "Well this news confirms our initial opinions on Brilacidin's safety. Concerning Brilacidin's efficacy, we know from the earlier phase 2a study the drug is amazingly effective and can stand up to any potential competitor. Add in the facts that we are seeking a one-time dose regimen and the belief that antibiotic resistance to Brilacidin is highly unlikely to develop, we are very optimistic we have a winner. Brilacidin breaches the bacteria's cell wall. How do you build resistance to a bullet? Enrollment in the study is now approximately 80% complete. We look forward to the completion of the double-blind trial, which is anticipated in October, when we can then break the blind and see efficacy results as well as know if the existing drug safety profile continued throughout the remainder of enrollment. Add in the potential of Brilacidin for oral mucositis, diabetic foot ulcers, and eye and ear diseases, and you can understand what a game changer this drug alone brings to Cellceutix shareholders."
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is presently in a bioequivalence crossover clinical trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT:
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Mar. 30, 2015 06:00 PM EDT Reads: 1,525
Today, IT is not just a cost center. IT is an enabler and driver of business. With the emergence of the hybrid cloud paradigm, IT now has increasingly more capabilities to create new strategic opportunities for a business. Hybrid cloud allows an organization to utilize multi-tenant public clouds, dedicated private clouds, bare metal hosting, and the associated support and services for the right use cases through an on-demand, XaaS model. This model of IT creates tremendous opportunities for busi...
Mar. 30, 2015 05:00 PM EDT Reads: 3,315
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting we...
Mar. 30, 2015 05:00 PM EDT Reads: 1,473
SYS-CON Events announced today that the DevOps Institute has been named “Association Sponsor” of SYS-CON's DevOps Summit, which will take place on June 9–11, 2015, at the Javits Center in New York City, NY. The DevOps Institute provides enterprise level training and certification. Working with thought leaders from the DevOps community, the IT Service Management field and the IT training market, the DevOps Institute is setting the standard in quality for DevOps education and training.
Mar. 30, 2015 04:30 PM EDT Reads: 1,224
Business as usual for IT is evolving into a “Make or Buy” decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud busi...
Mar. 30, 2015 04:15 PM EDT Reads: 1,509
Businesses are looking to empower employees and departments to do more, go faster, and streamline their processes. For all workers – but mobile workers especially – utilizing the cloud to reconnect documents and improve processes without destructing existing workflows can have a dramatic impact on productivity. In his session at 16th Cloud Expo, Mark Grilli, vice president of Acrobat Solutions marketing at Adobe Systems Incorporated, will outline new ways that the cloud is changing the way peo...
Mar. 30, 2015 04:00 PM EDT Reads: 1,382
SYS-CON Events announced today that QTS Realty Trust, one of the nation’s largest and fastest-growing providers of data center facilities and cloud services and a leader in security and compliance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. QTS Realty Trust, Inc. (NYSE: QTS) is a leading national provider of data center solutions and fully managed services, and a leader in security and compliance...
Mar. 30, 2015 03:00 PM EDT Reads: 1,329
SYS-CON Events announced today that Solgenia will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Solgenia is the global market leader in Cloud Collaboration and Cloud Infrastructure software solutions. Designed to “Bridge the Gap” between Personal and Professional S...
Mar. 30, 2015 03:00 PM EDT Reads: 2,924
SYS-CON Events announced today that WSM International (WSM), the world’s leading cloud and server migration services provider, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. WSM is a solutions integrator with a core focus on cloud and server migration, transformation and DevOps services.
Mar. 30, 2015 03:00 PM EDT Reads: 1,361
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY., and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MangoApps provides private all-in-one social intranets allowing workers to securely collaborate from anywhere in the world and from any device. Social, mobile, and eas...
Mar. 30, 2015 03:00 PM EDT Reads: 3,111
WSM International has launched a DevOps services division that offers assessment, consulting and implementation to large enterprises and organizations with complex infrastructures. The concept of DevOps is to blend information technology (IT) software development with operations to optimize the computing infrastructure according to the specific needs of the organization. According to a recent press release from Gartner, "By 2016, DevOps will evolve from a niche strategy employed by large cloud ...
Mar. 30, 2015 03:00 PM EDT Reads: 1,369
Sematext is a globally distributed organization that builds innovative Cloud and On Premises solutions for performance monitoring, alerting and anomaly detection (SPM), log management and analytics (Logsene), and search analytics (SSA). We also provide Search and Big Data consulting services and offer 24/7 production support for Solr and Elasticsearch.
Mar. 30, 2015 02:15 PM EDT Reads: 1,537
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, will explain the best practices of continuous testing at high scale, which is r...
Mar. 30, 2015 02:00 PM EDT Reads: 2,034
Modern Systems announced completion of a successful project with its new Rapid Program Modernization (eavRPMa"c) software. The eavRPMa"c technology architecturally transforms legacy applications, enabling faster feature development and reducing time-to-market for critical software updates. Working with Modern Systems, the University of California at Santa Barbara (UCSB) leveraged eavRPMa"c to transform its Student Information System from Software AG's Natural syntax to a modern application lev...
Mar. 30, 2015 01:00 PM EDT Reads: 1,056
DevOps is all the rage these days and with good reason as it promises to reduce the time-to-market for new applications. It also promises to improve change management, allowing teams to deploy changes to their applications quickly and efficiently. However, DevOps isn’t something you buy, install, or implement; rather it is the symptom of an appropriate organizational system. In his session at DevOps Summit, Mark Thiele, EVP, Data Center Technologies at SUPERNAP International, will discuss how ...
Mar. 30, 2015 01:00 PM EDT Reads: 1,469